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The FDA said it could not approve AbbVie’s new drug application (NDA) for ABBV-951 (foslevodopa/foscarbidopa), an investigational therapy for advanced Parkinson’s disease, because of concerns about the delivery device. Read More
The Centers for Medicare and Medicaid Services (CMS) has given Applied VR a unique payment code — the first for a virtual reality (VR) device — for its RelieVRx, providing a pathway for Medicare and Medicaid to cover the device as durable medical equipment (DME).
Four out of 10 women don’t receive the appropriate diagnosis and treatment for their vaginitis symptoms after an initial physician visit, which leads to additional visits because of persistent symptoms, the company said.
Among the many requirements to bring your product to market is to have accurate labeling — as well as procedures in place to ensure that and any new intended uses are included.